FDA device listing
FilmArray BioThreat-E Test
FDA device listing 1805100034 · BIOMERIEUX SA
Key facts
| Proprietary names | FilmArray BioThreat-E Test |
|---|---|
| Owner/operator | BIOMERIEUX SA |
| Owner/operator number | 8020790 |
| Product codes | POG |
| Device names | POG - Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid |
| Device class | Not classified |
| Classification regulations (21 CFR) | ORCA1.POG |
| Review panels | Microbiology |
| Registered establishments | BioFire Defense, LLC |
| Establishment registrations | 3010770794 |
| FEI numbers | 3010770794 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database